A Clinical Trial of Fluvoxamine for Melancholia

Lingjiang Li

Status and phase: Unknown; Phase 2

Conditions: Endogenous Depression; Melancholia; Depressive Disorder

Treatments: Drug: Fluvoxamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04160377

19-08-01-XY-0001

Details and patient eligibility

About

This study aims at investigating the special effectiveness of antidepressant effect of Fluvoxamine for endogenous depression. The investigators also aim to assess the effect of Fluvoxamine on the multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. The investigators further aim to identify the predictors of Fluvoxamine's antidepressant effeect using the above techniques.

Full description

This study aims at investigating the special effectiveness of antidepressant effect of Fluvoxamine for melancholia. The investigators also aim to assess the effect of Fluvoxamine on the multimodal magnetic resonance imaging(MRI), blood cytokines, feces bacteria flora and neuropsychological performance in depression patients with melancholic features. The investigators further aim to identify the predictors of Fluvoxamine's antidepressant effeect using the above techniques.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult (18-55 years, both sexes), with DSM-4 criteria for MDD without psychosis, as determined by a structured clinical interview Mini International Neuropsychiatric Interview
• Moderate to severe depression, as defined by a pretreatment score ≥17 on the HDRS-17 scale
• Informed consent to participate in this study
• ethinic Han, right-handed, Junior high school education or above

Exclusion criteria

• A history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented Axis II diagnoses; active suicidal intention, as determined by clinical interview
• Active or recent (<12 months) substance abuse or dependence; excluding nicotine
• Presence of ECT treatment in recent 6 months
• period of pregnancy or lactation
• hearing disorder or colour blindness
• Immediate relatives have bipolar disorder or mania disorder

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

melancholic depression

Experimental group

Description:

patients with melancholic depression undergo the treatment of Fluvoxamine

Treatment:

Drug: Fluvoxamine

non-melancholic depression

Experimental group

Description:

patients with non-melancholic depression undergo the treatment of Fluvoxamine

Treatment:

Drug: Fluvoxamine